The Effect of Hinge Location on Corneal Sensation and Dry Eye After LASIK: A Systematic Review and Meta-analysis

Dry Eye Clinical Trial

Official title:

The Effect of Hinge Location on Corneal Sensation and Dry Eye After LASIK: A Systematic Review and Meta-analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507025
• Other study ID #: Y20110045
• Status: Completed
• Phase: N/A
• First received: January 5, 2012
• Last updated: February 12, 2014
• Start date: October 2011
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the possible effect of hinge location on corneal sensation and dry eye syndrome after laser in situ keratomileusis (LASIK).

Description:

Dry eye symptoms are a frequent postoperative complication of laser in situ keratomileusis (LASIK). Although estimates of the incidence of dry eye syndrome vary widely, from 3% to 59%, almost all patients will have transient dry eye during the immediate postoperative period.Because of the variability in corneal innervation patterns, altering flap characteristics in LASIK may affect postoperative corneal sensation and dry-eye disease. Some studies have reported that postoperative corneal sensation may be higher and recovery faster in eyes with horizontal flaps (nasal- or temporal-hinge) than in eyes with vertical flaps (superior- hinge). However, some other studies have not established an association between corneal sensation and hinge position. This study reviewed the published literature and performed a meta-analysis aimed to investigate the effects of hinge location on corneal sensation and dry-eye symptoms after LASIK.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. each trial should be a prospective randomized controlled clinical trial (RCT),

2. the age of patient population should be over 18 years

Exclusion Criteria:

1. non-randomized controlled trials

2. patients who had had a previous ophthalmic surgery or ocular surface disorders

3. the raw data was not completed

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
China	Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Yifan Feng	Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal sensitivity	Change of corneal sensitivity by using the Cochet-Bonnet esthesiometer,we chose to analyze results at 1 week and 1-, 3-, 6-month postoperatively.	6 months	No
Primary	Tear break-up time	Change of tear break-up time at 1 week and 1-, 3-, 6-month postoperatively	6 months	No
Primary	Schirmer's I test	Change of Schirmer's I score at 1 week and 1-, 3-, 6-month postoperatively	6 months	No
Secondary	Corneal fluorescein staining		6 months	No